SAPIEN M3 System for Mitral Regurgitation

(SAPIEN M3 EFS Trial)

Recruiting at 8 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Edwards Lifesciences

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial will test the safety and effectiveness of the SAPIEN M3 System in patients with severe mitral regurgitation. The device is designed to help the heart valve close properly, preventing blood from flowing backward. The study aims to gather information for future research on this treatment. The SAPIEN M3 System is part of the SAPIEN family of heart valves, which have been used in various applications including aortic and mitral valve replacements.

Eligibility Criteria

This trial is for adults with severe mitral valve regurgitation who are at high risk for heart surgery, stable on heart failure meds, and not pregnant. They must understand the study and consent to it. Excluded are those with other valve issues, mechanical aortic valves, history of certain cardiovascular events or procedures within specified time frames, participation in another study, refusal of blood products, specific cardiac conditions that could interfere with treatment effectiveness or safety.

Inclusion Criteria

I am 18 years old or older.

You have heart problems that affect your ability to do physical activities.

The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria

Your heart's shape would make it difficult to put in the device or valve correctly.

I have kidney problems or am on dialysis.

I have liver disease or abnormal liver test results.

Treatment Details

Interventions

• Edwards SAPIEN M3 System (Transcatheter Mitral Valve Repair)

Trial Overview The Edwards SAPIEN M3 System is being tested to see if it's safe and works well for treating severe symptomatic mitral regurgitation (MR). The trial will help design future studies by collecting initial data on this new medical device's performance.

Participant Groups

Group I: TMVR Experimental Treatment 1 Intervention

Subjects will undergo transcatheter mitral valve replacement

Who Is Running the Clinical Trial?

Edwards Lifesciences

Lead Sponsor

Trials

188

Recruited

67,500+

Founded

1958

Headquarters

Irvine, California, U.S.

Known For

Structural Heart Innovations

Top Products

SAPIEN Transcatheter Heart Valve, EVOQUE System, PASCAL Precision, SAPIEN M3

Todd Brinton

Edwards Lifesciences

Chief Medical Officer since 2023

MD from Stanford University

Bernard Zovighian

Edwards Lifesciences

Chief Executive Officer since 2023

MBA from INSEAD